制药生产环境用消毒剂国内外标准比对

Comparison of domestic and foreign standards for disinfectants used in pharmaceutical manufacturing environment

目的:对国内外制药环境用消毒剂标准进行比对,探讨中国药典消毒剂相关标准制定的方向。方法:对美、日两国药典、《消毒技术规范》2002版和欧洲标准从消毒剂分类、效能验证方法等方面分别进行对比和讨论。结果与结论:国外药典是建立中国药典消毒剂标准的主要参考,行业标准可在方法上作出补充。

Objective:To compare domestic and foreign standards for disinfectants used in pharmaceutical manufacturing environment,and discuss the direction of the disinfectant standards in the Chinese Pharmacopoeia.Method:In the United States Pharmacopoeia,the Japanese Pharmacopoeia,the Technical Specification for Disinfection(2002)and the European Standard,the classification and efficacy verification methods of disinfectants were compared and discussed.Results and conclusion:The foreign pharmacopoeias were the main reference for the establishment of the disinfectant standards in the Chinese Pharmacopoeia,and other standards can be supplementary for the efficacy verification methods.